PET Imaging Study to Evaluate the mGlu5r Occupancy Following ADX48621 (Dipraglurant) Administration

NCT02447640 | Completed Phase 1

• 1 other identifier: ADX48621-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label study, non-randomized, positron emission tomography (PET)study investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy subjects using \[18F\]-FPEB as the radiotracer.

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the maximum receptor occupancy and EC 50 for the receptor occupancy/ADX48621 plasma concentration relationship

  This is composite

  During Day 1 PET scan

Study Arms (2)

Part 1

EXPERIMENTAL

A receptor occupancy dose curve will be obtained by using an adaptive design in this arm.

Drug: ADX48621; Radiation: [18F]FPEB

Part 2

EXPERIMENTAL

In this arm, the time course of the receptor occupancy will be studied for the dose which gives 70% receptor occupancy as determined in Part 1.

Drug: ADX48621; Radiation: [18F]FPEB

Interventions

ADX48621 DRUG

ADX4862, an investigational compound, is a potent, selective, negative allosteric modulator of the metabotropic glutamate receptor 5 (mGlu5 NAM).

Also known as: dipraglurant

Part 1; Part 2

[18F]FPEB RADIATION

radiotracer used for PET scanning

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females, 18-60 years old
• BMI of 18-32 kg/m2
• Female subjects must meet one of the following criteria:Surgically sterile (e.g. hysterectomy, or bilateral oophorectomy, tubal ligation) for at least 6 months prior to screening or Postmenopausal (no menstrual bleeding for at least 1 year prior to screening and confirmed by a plasma FSH level of \> 40 IU/L) or Non-pregnant, non- lactating women of child-bearing potential and practicing contraception (e.g. hormonal birth control, intra uterine device, condom and spermicide)
• Able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if:

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or any psychiatric disorder (as determined by the Investigator).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy and hernia repair will be allowed).
• Use of any tobacco-containing or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to consent.
• Poor peripheral venous access.
• Participation in any clinical drug study within 30 days prior to dosing.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Addex Pharma S.A.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

6-fluoro-2-(4-(pyridin-2-yl)but-3-yn-1-yl)imidazo(1,2-a)pyridine

Study Officials

• Dean F Wong, MD,PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: May 19, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (1)